Connection system for medical device components

ABSTRACT

A connection system for connecting a first medical device component to a second medical device component is disclosed. The connection system of the present disclosure provides for quick and intuitive coupling and decoupling of two opposing medical device components through the use of a connection path and a disconnection path, the connection path being distinct from the disconnection path. Furthermore, the connection system of the present disclosure provides audible and tactile connection feedback through the use of elastically deformable connection elements.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. patent application Ser. No.14/204,468, filed Mar. 11, 2014, which claims priority to U.S.Provisional Application No. 61/787,674, filed Mar. 15, 2013, and to U.S.Provisional Application Nos. 61/895,168, 61/895,182, and 61/895,187,which were each filed on Oct. 24, 2013. The disclosures of the patentapplications mentioned above are each hereby incorporated by referencein its entirety.

BACKGROUND OF THE INVENTION 1. Field of the Disclosure

The present disclosure relates generally to a connection system. Moreparticularly, the present disclosure relates to a connection system fora first medical device component and a second medical device component.

2. Description of the Related Art

Some medical components, such as intravenous line connectors, requireconnection to other components, such as to intravenous lines or tosyringe adapter or injector assemblies. Typical connection systems formedical device components include a single path for connection anddisconnection. Such connection systems involve reverse movements in thesame path for connection and disconnection. There is a need for aconnection system for medical device components that is intuitive toconnect and disconnect while minimizing the risk of inadvertentdisconnection.

SUMMARY OF THE INVENTION

The present disclosure provides a connection system for connecting afirst medical device component to a second medical device component. Theconnection system of the present disclosure provides for quick andintuitive coupling and decoupling of two opposing medical devicecomponents through the use of a connection path and a disconnectionpath, the connection path being distinct from the disconnection path.Furthermore, the connection system of the present disclosure providesaudible and tactile connection feedback through the use of elasticallydeformable connection elements.

In accordance with an embodiment of the present invention, a systemincludes a first medical device component having a first end, a secondend, and a sidewall extending therebetween, the sidewall having anexterior surface and an interior surface, the interior surface of thesidewall having a first projecting element; and a second medical devicecomponent having a first connection channel, a first disconnectionchannel, and a first securement element disposed between the firstconnection channel and the first disconnection channel, the firstconnection channel distinct from the first disconnection channel,wherein with the first projecting element of the first medical devicecomponent received within the first connection channel of the secondmedical device component, the first connection channel guides the firstprojecting element to the first securement element, wherein with thefirst projecting element engaged with the first securement element, thefirst medical device component is secured to the second medical devicecomponent, and wherein with the first projecting element of the firstmedical device component received within the first disconnection channelof the second medical device component, the first disconnection channelguides the first projecting element out from the first disconnectionchannel thereby disengaging the first medical device component from thesecond medical device component

In one configuration, the first medical device component is an injectoradapter and the second medical device component is a vial adapter. Inanother configuration, the first medical device component is an injectoradapter and the second medical device component is an IV line adapter.In yet another configuration, the interior surface of the sidewall ofthe first medical device component includes a second projecting elementspaced from the first projecting element. In one configuration, thesecond medical device component further includes a second connectionchannel, a second disconnection channel, and a second securement elementdisposed between the second connection channel and the seconddisconnection channel, the second connection channel distinct from thesecond disconnection channel. In another configuration, with the secondprojecting element of the first medical device component received withinthe second connection channel of the second medical device component,the second connection channel guides the second projecting element tothe second securement element, wherein with the second projectingelement engaged with the second securement element, the first medicaldevice component is secured to the second medical device component, andwherein with the second projecting element of the first medical devicecomponent received within the second disconnection channel of the secondmedical device component, the second disconnection channel guides thesecond projecting element out from the second disconnection channelthereby disengaging the first medical device component from the secondmedical device component. In yet another configuration, the secondmedical device component further includes a first step member disposedbetween the first securement element and the first disconnection channeland a second step member disposed between the second securement elementand the second disconnection channel. In one configuration, with thefirst projecting element engaged with the first securement element,rotation of the first medical device component in a counter-clockwisedirection relative to the second medical device component disengages thefirst projection element from the first securement element and moves thefirst projection element over the first step member and into the firstdisconnection channel. In another configuration, with the secondprojecting element engaged with the second securement element, rotationof the first medical device component in a counter-clockwise directionrelative to the second medical device component disengages the secondprojection element from the second securement element and moves thesecond projection element over the second step member and into thesecond disconnection channel. In yet another configuration, with thefirst projecting element engaged with the first securement element,rotation of the first medical device component in a clockwise directionrelative to the second medical device component disengages the firstprojection element from the first securement element and moves the firstprojection element over the first step member and into the firstdisconnection channel. In another configuration, with the secondprojecting element engaged with the second securement element, rotationof the first medical device component in a clockwise direction relativeto the second medical device component disengages the second projectionelement from the second securement element and moves the secondprojection element over the second step member and into the seconddisconnection channel. In yet another configuration, the firstprojecting element includes an elastically deformable tab. In oneconfiguration, the first securement element includes a recess.

In accordance with another embodiment of the present invention, a systemincludes an injector adapter enclosing a cannula, the injector adapterhaving a first end, a second end, and a sidewall extending therebetween,the sidewall having an exterior surface and an interior surface, theinterior surface of the sidewall having a first projecting element; anda vial adapter attachable to a vial, the vial adapter having a vialseal, a first connection channel, a first disconnection channel, and afirst securement element disposed between the first connection channeland the first disconnection channel, the first connection channeldistinct from the first disconnection channel, wherein with the firstprojecting element of the injector adapter received within the firstconnection channel of the vial adapter, the first connection channelguides the first projecting element to the first securement element,wherein with the first projecting element engaged with the firstsecurement element, the injector adapter is secured to the vial adapter,and wherein with the first projecting element of the injector adapterreceived within the first disconnection channel of the vial adapter, thefirst disconnection channel guides the first projecting element out fromthe first disconnection channel thereby disengaging the injector adapterfrom the vial adapter.

In one configuration, the interior surface of the sidewall of theinjector adapter includes a second projecting element spaced from thefirst projecting element. In another configuration, the vial adapterfurther includes a second connection channel, a second disconnectionchannel, and a second securement element disposed between the secondconnection channel and the second disconnection channel, the secondconnection channel distinct from the second disconnection channel. Inyet another configuration, with the second projecting element of theinjector adapter received within the second connection channel of thevial adapter, the second connection channel guides the second projectingelement to the second securement element, wherein with the secondprojecting element engaged with the second securement element, theinjector adapter is secured to the vial adapter, and wherein with thesecond projecting element of the injector adapter received within thesecond disconnection channel of the vial adapter, the seconddisconnection channel guides the second projecting element out from thesecond disconnection channel thereby disengaging the injector adapterfrom the vial adapter. In one configuration, the vial adapter furtherincludes a first step member disposed between the first securementelement and the first disconnection channel and a second step memberdisposed between the second securement element and the seconddisconnection channel. In another configuration, with the firstprojecting element engaged with the first securement element, rotationof the injector adapter in a counter-clockwise direction relative to thevial adapter disengages the first projection element from the firstsecurement element and moves the first projection element over the firststep member and into the first disconnection channel. In yet anotherconfiguration, with the second projecting element engaged with thesecond securement element, rotation of the injector adapter in acounter-clockwise direction relative to the vial adapter disengages thesecond projection element from the second securement element and movesthe second projection element over the second step member and into thesecond disconnection channel. In another configuration, with the firstprojecting element engaged with the first securement element, rotationof the injector adapter in a clockwise direction relative to the vialadapter disengages the first projection element from the firstsecurement element and moves the first projection element over the firststep member and into the first disconnection channel. In yet anotherconfiguration, with the second projecting element engaged with thesecond securement element, rotation of the injector adapter in aclockwise direction relative to the vial adapter disengages the secondprojection element from the second securement element and moves thesecond projection element over the second step member and into thesecond disconnection channel. In one configuration, the first projectingelement includes an elastically deformable tab. In anotherconfiguration, the second projecting element includes an elasticallydeformable tab. In yet another configuration, the first securementelement includes a recess. In one configuration, the second securementelement includes a recess.

In a further embodiment, a membrane for a medical connector includes abody having a first end and a second end with a sidewall extendingbetween the first end and the second end, the sidewall of the bodydefining an annular recess, the second end of the body defining a cavitythat extends toward the first end of the body, and the annular recessconfigured to receive a portion of a medical connector.

The first end of the body may include a convex surface. The cavity ofthe body may have a first end and terminate at a second end with thesecond end positioned at least about half a length of the body from thefirst end of the cavity. The second end of the cavity may define aconcave surface. The cavity may be wider at the first end of the cavitythan at the second end of the cavity. An annular projection may extendfrom the second end of the body. An inside corner defining the annularrecess may be radiused.

In another embodiment, a medical connector includes a connector bodydefining an interior space, and a membrane body having a first end and asecond end with a sidewall extending between the first end and thesecond end of the membrane body. The second end of the membrane bodydefining a cavity that extends toward the first end of the body, wherethe membrane body is secured to the connector body via an interferencefit, and where a portion of the membrane body is received within theinterior space of the connector body.

The sidewall of the membrane body may define an annular recess and theconnector body may include a projection extending into the interiorspace of the connector body, with the projection of the connector bodyreceived within the annular recess of the membrane body. The sidewalland the annular recess of the membrane body may establish theinterference fit with the connector body. The first end of the membranebody may extend beyond the connector body. The first end of the membranebody may include a convex surface.

In yet another embodiment, a method of assembling a medical connectorincludes: providing a connector body defining an interior space;positioning a membrane adjacent to the connector body with the membranecomprising a membrane body having a first end and a second end with asidewall extending between the first end and the second end of themembrane body, and the second end of the membrane body defining a cavitythat extends toward the first end of the body; and inserting a portionof the membrane body within the interior space of the connector body andelastically deforming the membrane body to secure the membrane to theconnector body via an interference fit.

The method may include: positioning an assembly tool on a first end ofthe connector body adjacent to the interior space, the assembly toolhaving a conical surface; and elastically deforming the membrane bodyprior to inserting the portion of the membrane body within the interiorspace of the connector body by engaging the conical surface of theassembly tool with the portion of the membrane body. The sidewall of themembrane body may define an annular recess and the connector body mayinclude a projection extending into the interior space of the connectorbody, with the method further including positioning the projection ofthe connector body within the annular recess of the membrane body.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is an exploded, perspective view of a first medical devicecomponent and a second medical device component including a connectionsystem in accordance with an embodiment of the present invention.

FIG. 2 is a detailed, fragmentary view of a portion of the first medicaldevice component and a portion of the second medical device component ofFIG. 1 including a connection system in accordance with an embodiment ofthe present invention.

FIG. 3 is a perspective view of a portion of a connection system of thepresent disclosure illustrating a connection path that is distinct froma disconnection path in accordance with an embodiment of the presentinvention.

FIG. 4 is a front elevation view of a first medical device component anda second medical device component including a connection system of thepresent disclosure illustrating an elastically deformable portion inaccordance with an embodiment of the present invention.

FIG. 5A is a perspective view of a first medical device componentconnected to a second medical device component by a connection system inaccordance with an embodiment of the present invention.

FIG. 5B is a cross-sectional view of the system of FIG. 5A taken alongline 5B-5B of FIG. 5A in accordance with an embodiment of the presentinvention.

FIG. 5C is a cross-sectional view of the system of FIG. 5A taken alongline 5C-5C of FIG. 5A in accordance with an embodiment of the presentinvention.

FIG. 6A is a perspective view of a first medical device componentconnected to a second medical device component by a connection system inaccordance with an embodiment of the present invention.

FIG. 6B is a cross-sectional view of the system of FIG. 6A taken alongline 6B-6B of FIG. 6A in accordance with an embodiment of the presentinvention.

FIG. 6C is a cross-sectional view of the system of FIG. 6A taken alongline 6C-6C of FIG. 6A in accordance with an embodiment of the presentinvention.

FIG. 7 is a perspective, cross-sectional view of a first medical devicecomponent connected to a second medical device component by a connectionsystem in accordance with an embodiment of the present invention.

FIG. 8A is a perspective view of a first medical device componentconnected to a second medical device component by a connection system inaccordance with an embodiment of the present invention.

FIG. 8B is a cross-sectional view of the system of FIG. 8A in accordancewith an embodiment of the present invention.

FIG. 8C is a cross-sectional view of the system of FIG. 8A taken alongline 8C-8C of FIG. 8A in accordance with an embodiment of the presentinvention.

FIG. 9A is an exploded, perspective view of a first medical devicecomponent and a second medical device component in accordance with anembodiment of the present invention.

FIG. 9B is a cross-sectional view of the system of FIG. 9A taken alongline 9B-9B of FIG. 9A in accordance with an embodiment of the presentinvention.

FIG. 10 is a perspective view of a first medical device componentconnected to a second medical device component by a connection system inaccordance with an embodiment of the present invention.

FIG. 11A is a perspective view of a first medical device componentconnected to a second medical device component by a connection system inaccordance with another embodiment of the present invention.

FIG. 11B is a side elevation view of a first medical device componentconnected to a second medical device component by a connection system inaccordance with an embodiment of the present invention.

FIG. 11C is a cross-sectional view of the first medical device componentconnected to the second medical device component taken along line11C-11C of FIG. 11B in accordance with an embodiment of the presentinvention.

FIG. 12A is a perspective view of an intravenous line adapter inaccordance with an embodiment of the present invention.

FIG. 12B is a top view of an intravenous line adapter in accordance withan embodiment of the present invention.

FIG. 12C is a perspective view of a first side of an intravenous lineadapter in accordance with an embodiment of the present invention.

FIG. 12D is a perspective view of a second side of an intravenous lineadapter in accordance with an embodiment of the present invention.

FIG. 13A is a perspective view of an intravenous line adapter inaccordance with an embodiment of the present invention.

FIG. 13B is a cross-sectional view of the intravenous line adapter ofFIG. 13A taken along line 13B-13B of FIG. 13A in accordance with anembodiment of the present invention.

FIG. 14A is a perspective view of an intravenous line adapter inaccordance with an embodiment of the present invention.

FIG. 14B is a cross-sectional view of the intravenous line adapter ofFIG. 14A taken along line 14B-14B of FIG. 14A in accordance with anembodiment of the present invention.

FIG. 15 is an exploded, perspective view of an injector adapter inaccordance with an embodiment of the present invention.

FIG. 16 is an assembled, cross-sectional view of the injector adapter ofFIG. 15 in accordance with an embodiment of the present invention.

FIG. 17 is another exploded, perspective view of an injector adapter inaccordance with an embodiment of the present invention.

FIG. 18 is a perspective view of an injector adapter in accordance withan embodiment of the present invention.

FIG. 19A is an exploded, perspective view of a vial adapter inaccordance with an embodiment of the present invention.

FIG. 19B is a side, perspective view of a vial adapter in accordancewith an embodiment of the present invention.

FIG. 19C is a perspective view of a vial adapter in accordance with anembodiment of the present invention.

FIG. 19D is a plan view of a vial adapter in accordance with anembodiment of the present invention.

FIG. 19E is a bottom view of a vial adapter in accordance with anembodiment of the present invention.

FIG. 19F is a cross-sectional view of the vial adapter of FIG. 19B inaccordance with an embodiment of the present invention.

FIG. 19G is a perspective view of a vial access system in accordancewith an embodiment of the present invention.

FIG. 20A is a perspective view of a vial adapter connected to a vial inaccordance with an embodiment of the present invention.

FIG. 20B is a cross-sectional view of the vial adapter connected to thevial of FIG. 20A in accordance with an embodiment of the presentinvention.

FIG. 21A is a perspective view of a vial adapter connected to a vial inaccordance with an embodiment of the present invention.

FIG. 21B is another perspective view of a vial adapter connected to avial in accordance with an embodiment of the present invention.

FIG. 21C is a cross-sectional view of a vial adapter connected to a vialtaken along line 21C-21C of FIG. 21B in accordance with an embodiment ofthe present invention.

FIG. 22 is an assembled, perspective view of a system in accordance withan embodiment of the present invention.

FIG. 23A is an assembled, perspective view of a system in accordancewith an embodiment of the present invention.

FIG. 23B is a cross-sectional view of the system taken along line23B-23B of FIG. 23A in accordance with an embodiment of the presentinvention.

FIG. 23C is a detailed, fragmentary view of FIG. 23B in accordance withan embodiment of the present invention.

FIG. 24 is a cross-sectional view of the system of FIG. 22 with thesystem inverted and a cannula seal in communication with a vial seal anda cannula in fluid communication with a substance contained within avial chamber in accordance with an embodiment of the present invention.

FIG. 25 is a cross-sectional view of the system of FIG. 22 with thesystem inverted and a cannula seal not in communication with a vial sealand a portion of a substance contained within a vial chamber transferredto a barrel chamber via a cannula in accordance with an embodiment ofthe present invention.

FIG. 26 is a cross-sectional view of the system of FIG. 25 with aportion of a substance contained within a vial chamber transferred to abarrel chamber via a cannula and the injector adapter positionedadjacent an intravenous line adapter in accordance with an embodiment ofthe present invention.

FIG. 27 is an exploded, perspective view of a first medical devicecomponent and a second medical device component including a connectionsystem in accordance with another embodiment of the present invention.

FIG. 28 is a perspective view of a connection system in accordance withanother embodiment of the present invention.

FIG. 29 is a cross-sectional view of the system of FIG. 28 in accordancewith another embodiment of the present invention.

FIG. 30 is a perspective view of a connector in accordance with anotherembodiment of the present invention.

FIG. 31 is a side, perspective view of a connector in accordance withanother embodiment of the present invention.

FIG. 32 is a perspective view of a membrane in accordance with anotherembodiment of the present invention.

FIG. 33 is a side elevation view of a membrane in accordance withanother embodiment of the present invention.

FIG. 34 is a perspective view of a first luer component in accordancewith another embodiment of the present invention.

FIG. 35 is a perspective view of a connection system and a first luercomponent connected to a second luer component and an IV line inaccordance with another embodiment of the present invention.

FIG. 36A is a cross-sectional view of a first step in assembling themembrane of FIG. 32 with a connector according to one embodiment of thepresent invention.

FIG. 36B is a cross-sectional view of a second step in assembling themembrane of FIG. 32 with a connector according to one embodiment of thepresent invention.

FIG. 36C is a cross-sectional view of a third step in assembling themembrane of FIG. 32 with a connector according to one embodiment of thepresent invention.

FIG. 37 is a cross-sectional view of a second step in assembling themembrane of FIG. 32 with a connector according to a further embodimentof the present invention.

DETAILED DESCRIPTION

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

The present disclosure provides a connection system for connecting afirst medical device component to a second medical device component.FIG. 1 illustrates the connection system of the present disclosureconnecting the housing of an injector adapter to an intravenous lineadapter according to an exemplary embodiment of the present disclosure.FIG. 11A illustrates the connection system of the present disclosureconnecting the housing of an injector adapter to a vial adapteraccording to another exemplary embodiment of the present disclosure.Furthermore, the connection system of the present disclosure may be usedto connect other medical device components.

Referring to FIGS. 15-18, injector adapter 12 generally includes acannula 20, a cannula seal 22, a spring 24, a needle hub 26, a cannulastabilizing member 28, a housing 29, a gliding ring 31, a one-way valve232, and a filter 234. Referring to FIG. 15, cannula 20 includes adistal end 30, a proximal end 32, and a lumen 34 extending therebetween.Distal end 30 is in fluid communication with proximal end 32 via lumen34 of cannula 20. As shown in FIG. 24, distal end 30 of cannula 20 iscapable of piercing cannula seal 22 and a vial seal membrane 344 toplace a vial chamber 96 in fluid communication with a barrel chamber 176via cannula 20. In one embodiment, distal end 30 of cannula 20 defines asharp point.

Injector adapter 12 is compatible with a system for the closed transferof fluids that provides substantially leak-proof sealing and pressurebalancing during engagement of a cannula with a vial, during transfer ofa substance from a vial chamber to a barrel chamber via the cannula, andduring disengagement of the cannula from the vial. Such a leak-proofsealing of the system substantially prevents leakage of both air andliquid during use of the system. The system is compatible with a needleand syringe assembly for accessing a medication contained within a vialfor administering the medication to a patient. The system is alsocompatible to be used with a drug reconstitution system.

Referring to FIGS. 15-18, cannula seal 22 generally includes aself-sealing seal secured over cannula 20 so that cannula seal 22encloses cannula 20 in a sealed position (FIG. 25) to provide asubstantially leak-proof seal preventing any liquid, air, or medicationresidue from being exposed to a health care provider transferring,reconstituting, transporting, or administering a drug using injectoradapter 12. Referring to FIG. 25, with cannula seal 22 in the sealedposition, cannula seal 22 encloses cannula 20 to also prevent accidentalneedle stick injuries to a user of injector adapter 12. Cannula seal 22includes a distal end 40, a proximal end 42, annular ribbed members 46extending therebetween, and a shoulder portion 44 (FIG. 16) located onan interior wall 48 near distal end 40 of cannula seal 22. In oneembodiment, distal end 40 of cannula seal 22 includes an annular cavity41. The distal end 40 of cannula seal 22 defines a convex surface andhas a transverse cross-sectional shape that is generally circular,although it is contemplated that other shapes and sizes of distal end 40may be used. For example, distal end 40 of cannula seal 22 can haveother multi-sided polygon cross-sectional shapes, such as square or ovalcross-sectional shapes. The cannula seal 22 may have a length that isabout equal to a length of the cannula 20 and, upon assembly of theinjector adapter 12, the cannula seal 22 may extend about the entirelength of the cannula 20.

In one embodiment, cannula seal 22 comprises a resilient material. Forexample, cannula seal 22 is preferably a unitary device molded of anyflexible, elastomeric material conventionally used for fabricatinggas-proof closures. Cannula seal 22 may be formed of a natural rubbermaterial, polyurethane elastomers, butyl rubbers, or similar materials.It is contemplated that cannula seal 22 is formed of a material having aShore A hardness of approximately 10 to 50. It is also envisioned thatcannula seal 22 can have other material hardness values that wouldprovide an appropriate self-sealing material to provide a substantiallyleak-proof seal with cannula seal 22 in the sealed position, therebypreventing any liquid or medication residue from being exposed to ahealth care provider transferring, reconstituting, transporting, oradministering a drug using injector adapter 12. In one embodiment,cannula seal 22 comprises a resilient sleeve.

Referring to FIG. 15, spring 24 includes a distal end 60 and a proximalend 62. Spring 24 provides a biasing force that promotes cannula seal 22to enclose cannula 20 in the sealed position as will be described inmore detail below. Referring to FIG. 16, spring 24 is disposed overcannula 20 such that spring 24 is radially positioned between cannula 20and cannula seal 22, i.e., cannula seal 22 encloses spring 24 andcannula 20.

Referring to FIG. 16, spring 24 is disposed over cannula 20 and withincannula seal 22 such that distal end 60 of spring 24 engages shoulderportion 44 of cannula seal 22. In this manner, spring 24 exerts thebiasing force on shoulder portion 44 of cannula seal 22. Shoulderportion 44 of cannula seal 22 also ensures that spring 24 is securedbetween shoulder portion 44 and needle hub 26.

Referring to FIGS. 15-18, needle hub 26 generally includes a distal end50 and a proximal end 52. Proximal end 52 of needle hub 26 includes abarrel connection portion 54. In one embodiment, barrel connectionportion 54 is a female luer connector that is configured to mate with amale luer connector, although other suitable connectors may be utilized.The barrel connection portion 54 includes a projection that isconfigured to be received by a corresponding threaded portion of themale luer connector. Other arrangements for the barrel connectionportion 54 may be utilized that deter undesired disconnection from theneedle hub 26. Needle hub 26 supports and is secured to a portion ofcannula 20. In one embodiment, the needle hub 26 is secured to thecannula 20 via an adhesive, such as an epoxy, although other suitablearrangements for securing the cannula 20 to the needle hub 26 may beutilized. Distal end 50 of needle hub 26 also provides a connection withproximal end 62 of spring 24 so that distal end 60 of spring 24 may becompressed relative to proximal end 62 of spring 24 when cannula 20pierces cannula seal 22 as will be described in more detail below. Withspring 24 compressed, spring 24 exerts a biasing force that promotescannula seal 22 to elastically enclose cannula 20. Referring to FIG. 25,in one embodiment, with cannula seal 22 in the sealed position, spring24 is loaded between shoulder portion 44 of cannula seal 22 and needlehub 26 in a slightly compressed position so that spring 24 exerts abiasing force that retains cannula seal 22 in the sealed position.

In one embodiment, referring to FIGS. 15-18, annular ribbed members 46of cannula seal 22 provide an additional biasing force that retainscannula seal 22 in the sealed position. Referring to FIG. 23C, ascannula 20 is brought into contact with vial adapter 14, annular ribbedmembers 46 of cannula seal 22 and spring 24 are compressed as cannula 20pierces cannula seal 22 and vial adapter 14. With annular ribbed members46 of cannula seal 22 compressed, annular ribbed members 46 exert anadditional biasing force that promotes cannula seal 22 to elasticallyenclose cannula 20.

Referring to FIGS. 15-18, housing 29 generally includes a distal orfirst end 110, a proximal or second end 112, and a sidewall 114extending therebetween. Sidewall 114 of housing 29 defines a housingchamber 115. Housing chamber 115 is sized and shaped to contain andhouse the components of injector adapter 12. The sidewall 114 of housing29 includes an exterior wall surface 116 and an interior wall surface118. In one embodiment, the interior wall surface 118 of the sidewall114 includes a connection element 120. Referring to FIG. 16, connectionelement 120 extends inwardly from interior wall surface 118 of sidewall114 into housing chamber 115 adjacent distal end 110. As discussed indetail below, connection element 120 is engageable with a connectionelement of a vial adapter or an IV line adapter to secure injectoradapter 12 to a vial adapter or an IV line adapter such that significantrelative movement between injector adapter 12 and the vial adapter or IVline adapter is prevented. In one embodiment, connection element 120comprises a first projecting member 121. In one embodiment, firstprojecting member 121 includes an elastically deformable tab forengagement with a connection element of a vial adapter or an IV lineadapter as described in more detail below. In one embodiment, referringto FIG. 4, housing 29 also includes an elastically deformable portionfor engagement with a connection element of a vial adapter or an IV lineadapter as described in more detail below.

In one embodiment, the interior wall surface 118 of the sidewall 114includes a second connection element 122. Referring to FIG. 17, secondconnection element 122 extends inwardly from interior wall surface 118of sidewall 114 into housing chamber 115 adjacent distal end 110. Secondconnection element 122 is spaced a distance from first connectionelement 120. In one embodiment, second connection element 122 is spacedapproximately 180 degrees (180°) from first connection element 120.Second connection element 122 is engageable with a connection element ofa vial adapter or an IV line adapter to secure injector adapter 12 to avial adapter or an IV line adapter. In one embodiment, second connectionelement 122 comprises a second projecting member 123. In one embodiment,second projecting member 123 includes an elastically deformable tab forengagement with a connection element of a vial adapter or an IV lineadapter as described in more detail below.

The first and second connection elements 120, 122 of injector adapter 12form a first portion of a connection system of the present disclosurewhich is compatible with connection elements of a vial adapter or an IVline adapter which form a second portion of a connection system of thepresent disclosure as discussed in more detail below.

In one embodiment, a material that is capable of elastic flexing withoutcracking is used to form first and second connection elements 120, 122of injector adapter 12. It is contemplated that flexible polymers may beused to form first and second connection elements 120, 122 of injectoradapter 12. For example, flexible polymers such as polyolefines may beused, e.g., polypropylene, polyethylene, and their co-polymers.

Housing 29 provides a protective housing which seals the components ofinjector adapter 12 within housing 29, i.e., housing 29 provides a leakprevention and protection enclosure, protects the components of injectoradapter 12 contained within housing 29, and/or maintains a sealed,sterilized environment within housing 29. Housing 29 also providesconnection elements 120, 122 which provide for engagement with aconnection element of a vial adapter or an IV line adapter to secureinjector adapter 12 to a vial adapter or an IV line adapter. In oneembodiment, referring to FIG. 4, housing 29 also includes an elasticallydeformable portion for engagement with a connection element of a vialadapter or an IV line adapter as described in more detail below.

Referring to FIGS. 15-18, in one embodiment, injector adapter 12includes cannula stabilizing member 28. Cannula stabilizing member 28includes a distal end 70, a proximal end 72, and an annular ring 74therebetween. Referring to FIG. 16, cannula stabilizing member 28 isdisposed within cannula seal 22 such that annular ring 74 of cannulastabilizing member 28 engages shoulder portion 44 of cannula seal 22. Inthis position, cannula stabilizing member 28 supports a portion ofcannula 20 and provides stability to cannula 20 during engagement ofcannula 20 with a vial or other device. With cannula stabilizing member28 positioned within cannula seal 22, spring 24 is disposed over cannula20 and within cannula seal 22 such that distal end 60 of spring 24engages annular ring 74 of cannula stabilizing member 28. In thismanner, spring 24 exerts the biasing force on annular ring 74 of cannulastabilizing member 28 which exerts the biasing force on shoulder portion44 of cannula seal 22.

Referring to FIGS. 16 and 17, in one embodiment, injector adapter 12includes gliding ring 31. Gliding ring 31 includes an exterior wallsurface, i.e., a gliding surface 252 and an interior surface 254. In oneembodiment, the interior surface 254 of gliding ring 31 includes anannular protrusion 256. The annular protrusion 256 extends radiallyinwards from interior surface 254. Referring to FIG. 16, gliding ring 31is disposed within housing 29 such that annular protrusion 256 isreceived within annular cavity 41 of cannula seal 22 to secure thegliding ring 31 to the cannula seal 22 such that the gliding ring 31 ispositioned between cannula seal 22 and interior wall surface 118 ofhousing 29. In this position, gliding ring 31 supports a portion ofcannula seal 22 and provides stability to cannula seal 22 within housing29 during engagement of cannula 20 with a vial or other device. Glidingring 31 also provides stability to cannula seal 22 with cannula seal 22moving within housing 29.

Referring to FIGS. 15-18, in one embodiment, injector adapter 12 isconfigured to provide an aspiration arrangement 230 to allow air toenter the injector adapter 12 for aspirating air into a syringe barrelwhile using seal and pressure equalization system 10. In particular, theaspiration arrangement 230 allows a user to aspirate air into the barrelchamber 176 after injector adapter 12 is secured to the barrel assembly16. In one embodiment, the aspiration arrangement 230 includes a one-wayvalve 232 and filter 234. As shown in FIG. 16, the needle hub 26includes an inner wall 236 and an outer wall 238 that defines an annularrecess 240. The needle hub 26 further defines at least one passageway242 that extends perpendicularly to a longitudinal axis of the hub 26.The passageway 242 extends through the inner wall 236. The outer wall238 defines a cutout 243 that is configured to receive the filter 234.The cutout 243 is in fluid communication with the passageway 242 and theannular recess 240. In one embodiment, as shown in FIGS. 15-17, thefilter 234 is a flat filter sheet positioned within the cutout 243,although other suitable arrangements may be utilized. For example, thefilter 234 may be ring-shaped and fitted within the annular recess 240rather than being positioned within the cutout 243. The filter 234 maybe any suitable commercially available filter, such as a particulate airfilter having a pore size of 0.2 μm or larger. The filter 234 may beconfigured remove viable micro-organisms.

Referring again to FIG. 16, in one embodiment, the one-way valve 232 isembodied as an extension 244 of the cannula seal 22 that extends intothe needle hub 26. The extension 244 is formed integrally with thecannula seal 22, although the extension 244 may be formed separately.The extension 244 of the cannula seal 22 abuts and extends along atleast a portion of an inner surface 246 of the inner wall 236. Theextension 244 is configured to selectively allow the flow of outside airthrough the passageway 242 and the filter 234 and into the cannula seal22. In particular, in response to a pressure drop within the cannulaseal 22 caused by aspiration, the extension 244 will deflect inwardly toopen the passageway 242 and allow outside air to be drawn into thebarrel chamber 176 of barrel assembly 16. After aspiration, theextension 244 will return to its original position to block or close thepassageways 242. When the cannula seal 22 is under a positive pressure,the extension 244 is forced radially outward and continues to block andseal the passageway 242. Air may first be injected into the vial chamber96 of vial 90 prior to withdrawing fluid, such as substance 98, from thevial chamber 96. Accordingly, the one-way valve 232 and filter 234allows a user to aspirate air into the barrel chamber 176 after theinjector adapter 12 is secured to the barrel assembly 16. Furthermore,the filter 234 is configured to filter the outside air that is aspiratedinto the barrel assembly 16, which advantageously allows clean filterair to be injected into the vial chamber 96.

Referring to FIGS. 22-26, proximal end 52 of needle hub 26 is attachedto a barrel 160 of barrel assembly 16. With needle hub 26 supporting aportion of cannula 20 and with proximal end 52 of needle hub 26 attachedto barrel 160 of barrel assembly 16, needle hub 26 attaches cannula 20to barrel assembly 16 such that cannula 20 is in fluid communicationwith barrel chamber 176 of barrel 160.

Referring to FIG. 23B, barrel assembly 16 includes barrel 160, a plungerrod 162, and a stopper 164. Barrel assembly 16 may be adapted for thedispensing and delivery of a fluid and/or collection of a fluid. Forexample, barrel assembly 16 may be used for injection or infusion offluid such as a medication into a patient. Barrel assembly 16 iscontemplated for use in connection with a needle, such as by connectingbarrel assembly 16 to cannula 20 as described, connecting barrelassembly 16 to a separate needle assembly (not shown), or alternatively,for connection with an intravenous (IV) connection assembly such as IVline adapter 18. It can be appreciated that the present disclosure canbe used with any type of syringe assembly, including, but not limitedto, metered dose syringes, aspiration syringes for withdrawing fluidfrom a patient or medication from a container or vial, and the like.

Referring to FIGS. 12A-14B, IV line adapter 18 includes first end 130and opposing second end 131. IV line adapter 18 provides a compact andaccessible connector for connecting a cartridge or barrel containing areconstituted drug to an intravenous line or an injection apparatus foradministering the drug to a patient.

First end 130 of IV line adapter 18 includes a connection system 132.Connection system 132 of IV line adapter 18 forms a portion of aconnection system of the present disclosure which is compatible with aconnection system 120, 122 of injector adapter 12 which form anotherportion of a connection system of the present disclosure as discussed inmore detail below.

Referring to FIGS. 12A-12C, in one embodiment, connection system 132includes a first connection element 133 disposed at first end 130 of IVline adapter 18 which is engageable with a connection element 120, 122of an injector adapter 12 to secure the injector adapter 12 to IV lineadapter 18. In one embodiment, first end 130 of IV line adapter 18includes a second connection element 134. Second connection element 134is spaced a distance from first connection element 133. In oneembodiment, second connection element 134 is spaced approximately 180degrees (180°) from first connection element 133. Second connectionelement 134 is engageable with a connection element 120, 122 of aninjector adapter 12 to secure the injector adapter 12 to IV line adapter18 such that significant relative movement between injector adapter 12and IV line adapter 18 is prevented.

Referring to FIGS. 12A-12C, first connection element 133 of connectionsystem 132 includes a first connection path 136, a first disconnectionpath 138, and a first securement element 140 disposed between the firstconnection path 136 and first disconnection path 138. In one embodiment,first connection path 136, first disconnection path 138, and firstsecurement element 140 together generally define a U-shaped path. Firstconnection path 136 is distinct from first disconnection path 138. Inthis manner, the distinct connection and disconnection paths allow forthe fine tuning of tactile and audible responses separately forconnection and disconnection movements. In one embodiment, divider wall139 is disposed between first connection path 136 and firstdisconnection path 138.

It is contemplated that most polymers may be used for first connectionelement 133 of IV line adapter 18. In one embodiment, a wide variety ofthermoplastic and thermosetting polymers and similar materials may beused to form first connection element 133 of IV line adapter 18. In oneembodiment, first connection element 133 of IV line adapter 18 is madefrom a rigid material such as a hard plastic, metal, or ceramicmaterial. The important characteristics of the materials used to makefirst connection element 133 of IV line adapter 18 is that they are amore rigid material than the materials used to form connection element120 of injector adapter 12.

In one embodiment, first connection path 136 comprises a firstconnection channel. In one embodiment, first disconnection path 138comprises a first disconnection channel. In one embodiment, firstsecurement element 140 comprises a locking recess.

First connection path 136 includes a connection guide surface 141, afirst connection guide wall 142, and a second connection guide wall 143which together form a channel that guides connection element 120 ofinjector adapter 12 to enter engagement with IV line adapter 18 asdescribed in more detail below. Connection guide surface 141 includes anentry portion 144 and an exit portion 145 adjacent securement element140. In one embodiment, guide surface 141 tapers upwards from entryportion 144 to exit portion 145. In this manner, guide surface 141receives, guides, and deforms connection element 120 of injector adapter12 as described in more detail below.

First connection path 136 includes a step member 135 disposed betweenfirst securement element 140 and first disconnection path 138. Stepmember 135 includes an exit recess step 147, an enter disconnection pathstep 148, and a top step surface 149 disposed therebetween. Step member135 provides a component that allows connection element 120 of injectoradapter to be rotated out from engagement with securement element 140.Also, step member 135 can be used to tune resistance and provide tactilefeel during a disconnection movement as described in more detail below.

First disconnection path 138 includes a disconnection guide surface 150,a first disconnection guide wall 151, and a second disconnection guidewall 152 which together form a channel that guides connection element120 of injector adapter 12 to exit IV line adapter 18 as described inmore detail below. Disconnection guide surface 150 includes an entryportion 153 adjacent step member 135 and an exit portion 154 thatincludes a barrier exit wall 155. In one embodiment, guide surface 150tapers upwards from entry portion 153 to exit portion 154. In thismanner, guide surface 150 receives, guides, and deforms connectionelement 120 of injector adapter 12 as described in more detail below.

Referring to FIGS. 12B and 12D, second connection element 134 ofconnection system 132 includes a second connection path 170, a seconddisconnection path 171, and a second securement element 172 disposedbetween the second connection path 170 and second disconnection path171. In one embodiment, second connection path 170, second disconnectionpath 171, and second securement element 172 together generally define aU-shaped path. Second connection path 170 is distinct from seconddisconnection path 171. In this manner, the distinct connection anddisconnection paths allow for the fine tuning of tactile and audibleresponses separately for connection and disconnection movements. In oneembodiment, divider wall 174 is disposed between second connection path170 and second disconnection path 171.

It is contemplated that most polymers may be used for second connectionelement 134 of IV line adapter 18. In one embodiment, a wide variety ofthermoplastic and thermosetting polymers and similar materials may beused to form second connection element 134 of IV line adapter 18. In oneembodiment, second connection element 134 of IV line adapter 18 is madefrom a rigid material such as a hard plastic, metal, or ceramicmaterial. The important characteristics of the materials used to makesecond connection element 134 of IV line adapter 18 is that they are amore rigid material than the materials used to form second connectionelement 122 of injector adapter 12.

In one embodiment, second connection path 170 comprises a secondconnection channel. In one embodiment, second disconnection path 171comprises a second disconnection channel. In one embodiment, secondsecurement element 172 comprises a locking recess.

Second connection path 170 includes a connection guide surface 180, afirst connection guide wall 181, and a second connection guide wall 182which together form a channel that guides second connection element 122of injector adapter 12 to enter engagement with IV line adapter 18 asdescribed in more detail below. Connection guide surface 180 includes anentry portion 183 and an exit portion 184 adjacent securement element172. In one embodiment, guide surface 180 tapers upwards from entryportion 183 to exit portion 184. In this manner, guide surface 180receives, guides, and deforms second connection element 122 of injectoradapter 12 as described in more detail below.

Second connection path 170 includes a step member 173 disposed betweensecond securement element 172 and second disconnection path 171. Stepmember 173 includes an exit recess step 191, an enter disconnection pathstep 192, and a top step surface 193 disposed therebetween. Step member173 provides a component that allows second connection element 122 ofinjector adapter 12 to be rotated out from engagement with securementelement 172. Also, step member 173 can be used to tune resistance andprovide tactile feel during a disconnection movement as described inmore detail below.

Second disconnection path 171 includes a disconnection guide surface185, a first disconnection guide wall 186, and a second disconnectionguide wall 187 which together form a channel that guides secondconnection element 122 of injector adapter 12 to exit IV line adapter 18as described in more detail below. Disconnection guide surface 185includes an entry portion 188 adjacent step member 173 and an exitportion 189 that includes a barrier exit wall 190. In one embodiment,guide surface 185 tapers upwards from entry portion 188 to exit portion189. In this manner, guide surface 185 receives, guides, and deformssecond connection element 122 of injector adapter 12 as described inmore detail below.

First end 130 of IV line adapter 18 includes a pierceable barriermembrane 158. The pierceable barrier membrane 158 provides for a liquidand gas tight seal between a piercing member of a barrel assembly andthe pierceable barrier membrane 158 during fluid transfer of amedication to a patient so to minimize leakage and thereby preventexposure of hazardous medicaments to a user. Barrier membrane 158provides a self-sealing seal that, with a barrel assembly attached to IVline adapter 18, provides a leak-proof seal preventing any substancebeing administered to a patient from being exposed to a health careprovider administering the medication. In one embodiment, barriermembrane 158 comprises a resilient material. For example, barriermembrane 158 is preferably a unitary device molded of any flexible,elastomeric material conventionally used for fabricating gas-proofclosures. Barrier membrane 158 may be formed of a natural rubbermaterial, polyurethane elastomers, butyl rubbers, or similar materials.

Referring to FIGS. 19A-19G, vial adapter 14 includes a vial accesssystem 312 and a pressure equalization system 314. Vial adapter 14 isconfigured to establish fluid communication between a first containerand a second container. For example, vial adapter 14 is attachable to avial 90. Referring to FIGS. 20A and 20B, vial 90 may be a standard drugvial of any type having an open head portion 93 covered by a pierceableseptum 94 of an elastomeric material. Walls 95 of vial 90 define vialchamber 96 for containing a substance 98. Vial septum 94 is engaged withhead portion 93 of vial 90 to seal the substance 98 within vial chamber96.

Vial adapter 14 is compatible with a system for the closed transfer offluids that provides substantially leak-proof sealing and pressurebalancing during engagement of a cannula with a vial, during transfer ofa substance from a vial chamber to a barrel chamber via the cannula, andduring disengagement of the cannula from the vial.

As shown in FIGS. 19A-19F, with pressure equalization system 314 securedto vial access system 312, vial adapter 14 includes first end 302,opposing second end 303, and wall 304 extending between first end 302and second end 303. Wall 304 defines an exterior profile 306 as will bedescribed in more detail below. With vial adapter 14 attached to a vial90, the vial adapter 14 provides a leak-proof seal and pressureequalization system that prevents any substance contained within achamber of the vial from being exposed to a health care providerreconstituting, transporting, or administering a drug.

The fit between vial adapter 14 and the packaging member provides asecure fit therebetween, such that, with vial adapter 14 received withinthe packaging member, the packaging member can be used as an interfacebetween the hand of a user and vial adapter 14 so that vial adapter 14can be placed onto a vial without taking vial adapter 14 out of thepackaging member.

Referring to FIG. 19G, vial access system 312 of vial adapter 14includes vial access housing 330 having first end 332 and opposingsecond end 334. First end 332 of vial access housing 330 includes aconnection element or connection system 336. First connection element336 is engageable with a connection element 120, 122 of an injectoradapter 12 to secure the injector adapter 12 to vial adapter 14. In oneembodiment, first end 332 of vial access housing 330 includes a secondconnection element or second connection system 339. Second connectionelement 339 is spaced a distance from first connection element 336. Inone embodiment, second connection element 339 is spaced approximately180 degrees (180°) from first connection element 336. Second connectionelement 339 is engageable with a connection element 120, 122 of aninjector adapter 12 to secure the injector adapter 12 to vial adapter 14such that significant relative movement between injector adapter 12 andvial adapter 14 is prevented.

In one embodiment, the first and second connection elements 336, 339 ofvial adapter 14 form a second portion of a connection system of thepresent disclosure which is compatible with connection elements of aninjector adapter which form a first portion of a connection system ofthe present disclosure as discussed in more detail below.

FIGS. 19A-19G illustrate another exemplary embodiment of the presentdisclosure. The connection system of first and second connectionelements 336, 339 of vial adapter 14 illustrated in FIGS. 19A-19Ginclude similar components to the connection system of first connectionelement 133 and second connection element 134 of IV line adapter 18illustrated in FIGS. 12-14B, and the similar components are denoted by areference number followed by the letter A. For the sake of brevity,these similar components and the similar steps of using the connectionsystem of first and second connection elements 336, 339 of vial adapter14 will not all be discussed in conjunction with the embodimentillustrated in FIGS. 19A-19G.

First end 332 of vial access housing 330 is substantially formed by aneck portion 333. In one embodiment, neck portion 333 may include aguiding groove arranged therein to guide corresponding guidingprotrusions on a cannula adapter or syringe assembly, for example, toestablish a secure attachment between the cannula adapter or syringeassembly and vial adapter 14 after which fluid communication can beestablished.

Referring to FIGS. 19A-19G, a vial connection member or vial engagementmember 337 is disposed at second end 334 of vial access housing 330. Inone embodiment, vial connection member 337 includes a plurality of vialgrip members 338 that are disposed at second end 334 of vial accesshousing 330. Vial grip members 338 are attachable to a vial 90 to securevial adapter 14 to the vial 90. Each vial grip member 338 includes ahook protrusion 340 arranged to engage a corresponding flange on acontainer such as a vial 90 as shown in FIGS. 20A and 20B. Vialconnection member 337 of vial access housing 330 may be dimensioned tobe attached to containers of any size and volume. In other embodiments,vial connection member 337 of vial access housing 330 may include otherconnection mechanisms for securing vial adapter 14 to vial 90 such as athreaded portion, a snap fit mechanism, locking tabs, or other similarmechanism.

A fluid transfer channel 342 extends substantially between first end 332and second end 334 of vial access housing 330. The purpose of fluidtransfer channel 342 is to permit a needle cannula to extend throughvial access housing 330 of vial adapter 14 and to thereby permit fluidto be transferred through vial adapter 14.

Referring to FIG. 20B, a pierceable barrier member or vial seal membrane344 is arranged in the fluid transfer channel 342 at first end 332 ofvial access housing 330. The pierceable barrier member 344 provides fora liquid and gas tight seal between a piercing member and the pierceablebarrier member 344 during fluid transfer so to minimize leakage andthereby prevent exposure of hazardous medicaments to a user. Vial sealmembrane 344 provides a self-sealing seal that, with vial adapter 14attached to vial 90 such that vial seal membrane 344 is aligned withvial septum 94, provides a leak-proof seal preventing any substancecontained within vial chamber 96 from being exposed to a health careprovider reconstituting, transporting, or administering a drug usingsystem 10. Referring to FIGS. 23C-25, vial seal membrane 344, vialsleeve seal 350, and cannula seal 22 provide a leak-proof seal that isliquid tight and airtight preventing any substance residue from beingexposed to a health care provider while reconstituting or withdrawingsubstance 98 from vial 90 to barrel 160 via cannula 20.

In one embodiment, vial seal membrane 344 comprises a resilientmaterial. For example, vial seal membrane 344 is preferably a unitarydevice molded of any flexible, elastomeric material conventionally usedfor fabricating gas-proof closures. Vial seal membrane 344 may be formedof a natural rubber material, polyurethane elastomers, butyl rubbers, orsimilar materials. It is contemplated that vial seal membrane 344 isformed of a material having a Shore A hardness of approximately 10 to50. It is also envisioned that vial seal membrane 344 can have othermaterial hardness values that would provide an appropriate self-sealingmaterial to provide a leak-proof seal with vial septum 94 of vial 90 andcannula seal 22, thereby preventing any liquid or medication residuefrom being exposed to a health care provider reconstituting,transporting, or administering a drug using system 10.

Protruding out from vial access housing 330 at second end 334 is apiercing member or spike member 346 which includes piercing tip 348. Inone embodiment, fluid transfer channel 342 extends inside of spikemember 346. The spike member 346 extends in a direction substantiallyparallel with the plurality of vial grip members 338 and serves thepurpose of piercing a fluid container such as a vial 90 during assemblyof vial adapter 14 to a vial 90 as is shown in greater detail in FIG.20B.

In one embodiment, a vial sleeve seal 350 is disposed over the spikemember 346. The vial sleeve seal 350 provides a seal between vialadapter 14 and a vial 90 with the piercing tip 348 of spike member 346engaged with the vial 90. In one embodiment, vial sleeve seal 350comprises a rubber spike sleeve.

Referring to FIGS. 19A-19F, pressure equalization system 314 includespressure equalization housing 360 and toroidal expandable balloon 362which includes an expansion chamber 366. Pressure equalization housing360 defines a tapered exterior wall portion 361 and an interior annularring cavity portion 363. In one embodiment, tapered exterior wallportion 361 includes a plurality of stabilizing ribs 365. In oneembodiment, stabilizing ribs 365 may extend in an axial direction alongtapered exterior wall portion 361 of pressure equalization housing 360and the ribs 365 may be spaced around a periphery of pressureequalization housing 360. Expandable balloon 362 includes a variablevolume. Pressure equalization housing 360 comprises a relatively rigidmaterial and expandable balloon 362 comprises a relatively flexiblematerial. In one embodiment, expandable balloon 362 comprises a thin,transparent plastic film that is attached to pressure equalizationhousing 360 in a gastight manner. In one embodiment, expandable balloon362 is designed as a bellow which is compressible and extendable andthus the volume of the expansion chamber 366 of expandable balloon 362can thereby be increased and decreased. In one embodiment, interiorannular ring cavity portion 363 of pressure equalization housing 360extends radially around vial access housing 330 and expandable balloon362 extends radially around vial access housing 330.

Pressure equalization housing 360 provides a barrier wall member thatprotects expandable balloon 362 from being torn during engagement of acannula with a vial, during transfer of a substance from a vial chamberto a barrel chamber via the cannula, and during disengagement of thecannula from the vial. In one embodiment, by having expandable balloon362 extending radially around the entirety of vial access housing 330,the vial adapter 14 is balanced such that a center of mass is positionedat about a longitudinal axis of vial adapter 14. In one embodiment,expandable balloon 362 extends 360 degrees (360°) radially around vialaccess housing 330. In one embodiment, a portion of toroidal expandableballoon 362 is not covered by pressure equalization housing 60. In thismanner, expandable balloon 362 is capable of expanding in an axialdirection.

In one embodiment, pressure equalization housing 360 and vial accesshousing 330 are a single integral component. In another embodiment,pressure equalization housing 360 and vial access housing 330 areseparate components and pressure equalization housing 360 is attachableto vial access housing 330 such that significant relative movementbetween pressure equalization housing 360 and vial access housing 330 isprevented.

Referring to FIG. 19F, a pressure normalization channel 370 extends fromsecond end 334 of vial access housing 330 to exit aperture 364 ofpressure equalization housing 360. Pressure normalization channel 370 isarranged to provide gas communication between the expandable balloon 362and the interior of a vial 90 when the vial adapter 14 is connected to avial 90. With vial adapter 14 connected to a vial 90, a syringe orcannula assembly may be used to inject fluid into the vial 90 or towithdraw fluid therefrom as described in more detail below. In oneembodiment, pressure normalization channel 370 extends from a portion ofpiercing tip 348 of spike member 346 and substantially parallel withfluid transfer channel 342 inside spike member 346. The pressurenormalization channel 370 diverts in a direction perpendicular to fluidtransfer channel 342 substantially at shoulder portion 372 of pressurenormalization channel 370. The pressure normalization channel 370includes an inlet opening 374 arranged substantially at a portion ofpiercing tip 348 of spike member 346 and an outlet opening 376positioned substantially at exit aperture 364 of pressure equalizationhousing 360.

Referring to FIGS. 19A and 19F, in one embodiment, the pressurenormalization channel 370 comprises a filter 380 arranged to cover aregion of the pressure normalization channel 370. The filter 380 servesthe purpose of preventing any fluid from a container, such as a vial,from reaching expansion chamber 366 of expandable balloon 362. In oneembodiment, the filter 380 is preferably a hydrophobic filter whichpermits gas to pass, but prevents liquid to pass. The filter 380 may besecured within pressure equalization housing 360 via filter holder 382.

In one embodiment, vial adapter 14 may also include a valve arrangementpositioned in the proximity of outlet opening 376 of the pressurenormalization channel 370. Such a valve arrangement prevents clogging ofthe filter 380 by providing a cracking pressure to the valve arrangementfor the fluid which flows in a direction from the inlet opening 374 tothe outlet opening 376 of the pressure normalization channel 370 whilepermitting preferably a minimal cracking pressure in the oppositedirection.

The function and advantages of vial adapter 14, according to the presentdisclosure, will be described in greater detail. When preparing andadministering drugs, care has be taken to minimize, or preferablyeliminate, the risk of exposing people, such as medical andpharmacological personnel, to toxic substances. Some drugs must bedissolved or diluted before they are administered, which involvestransferring a solvent from one container to a sealed vial containingthe drug in powder or liquid form, by means of a needle, for example.Drugs may be inadvertently released into the atmosphere in gas form orby way of aerosolization, during the withdrawal of the needle from thevial, and while the needle is inside the vial, if any pressuredifferential between the interior of the vial and surrounding atmosphereexists. Vial adapter 14 of the present disclosure eliminates thisproblem by using pressure equalization system 314 of vial adapter 14that may be attached to a vial during the preparation of drugs. Thepressure equalization system 314 includes an expandable balloon 362which in communication with the interior of the vial 90 ensures thatneither an increased pressure nor a vacuum can occur inside the vial 90when gas or liquid is injected into or withdrawn from the vial 90. Inone embodiment, the expandable balloon 362 may be filled with cleaned orsterilized air prior to its use to ensure that the contents of the vial90 do not become contaminated with air-borne particles such as dust,pollen, mold or bacteria, or other undesirable substances.

Referring to FIGS. 22-25, the vial adapter 14 is assembled via itsconnection element 336 of vial access housing 330 to a cannula 20 ofinjector adapter 12 which in turn can be connected to a fluid container,such as barrel assembly 16, and the vial adapter 14 is also assembledvia its vial connection members 337 with a second fluid container, suchas a vial 90. As vial adapter 14 is assembled with the vial 90, thepiercing tip 348 of the spike member 346 is pierced through a septum 94of the vial 90. Vial 90 may be a standard drug vial of any type havingan open head portion covered by a pierceable septum of an elastomericmaterial. The walls 95 of vial 90 define a vial chamber 96 forcontaining a substance 98. The vial septum 94 is engaged with the headportion 93 of vial 90 to seal a substance within vial chamber 96. Theplurality of vial grip members 338 fixedly connect vial adapter 14 tothe vial 90 as the hook protrusions 340 of vial grip members 338 engagethe corresponding flange 97 on vial 90 as shown in FIG. 20B. Afterassembly, a user is able to insert fluid into the vial 90, or optionallyto retract fluid from the vial 90.

As a fluid is inserted into the vial 90, using the cannula 20 and barrelassembly 16, an overpressure is created inside the vial 90. Pressureequalization system 314 of vial adapter 14 permits pressure equalizationbetween the vial 90 and the expandable balloon 362. The pressurenormalization channel 370 normalizes the pressure inside the vial 90 byrelieving the pressure inside the vial 90 to the expansion chamber 366of the expandable balloon 362 as shown in FIGS. 21A-21C.

In other words, FIGS. 22-25 and 21A-21C show the vial adapter 14attached to the vial 90 and with cannula 20 inserted through the vialadapter 14 and into the interior of the vial 90. As a fluid is injectedinto the vial 90, or withdrawn from the vial 90, the pressurenormalization channel 370 of the pressure equalization system 314 ofvial adapter 14 permits gas to flow from the interior of the vial 90into the expandable balloon 362 or from the expansion chamber 366 of theexpandable balloon 362 to the vial 90, and thereby equalizes thepressure in the interior of the vial 90. Gas may enter the expandableballoon 362 via outlet opening 376, however gas cannot exit from theexpandable balloon 362. This eliminates, or at least reduces the risk ofany substance inside the vial 90 from being released into the atmospherein gas form or by way of aerosolization during the insertion orwithdrawal of a needle from the vial 90 or while a needle is inserted inthe vial 90. It also eliminates, or reduces the risk of the vial 90deforming due to the increased pressure inside the vial 90, whereby suchdeformation may cause leakage of the vial's 90 contents due toseparation of the septum 94 of the vial 90 from the walls 95 of the vial90, for example.

Referring to FIGS. 1-11C, the use of a connection system of the presentdisclosure to connect a first medical device component, e.g., injectoradapter 12, to a second medical device component, e.g., IV line adapter18, will now be described.

Initially, the first connection element 120 of injector adapter 12 isaligned with the first connection path 136 of IV line adapter 18 and thesecond connection element 122 of injector adapter 12 is aligned with thesecond connection path 170 of IV line adapter 18 as shown in FIGS. 1, 2,and 9A. Next, a user can push injector adapter 12 and IV line adapter 18together so that first connection element 120 of injector adapter 12enters first connection path 136 of IV line adapter 18 and secondconnection element 122 of injector adapter 12 enters second connectionpath 170 of IV line adapter 18. The path that connection elements 120,122 of injector adapter 12 follow, through respective connection paths136, 170 of IV line adapter 18, is shown in the connection illustrationof FIG. 3. As connection elements 120, 122 of injector adapter 12 areguided through respective connection paths 136, 170 of IV line adapter18 from respective entry portions 144, 183 to respective exit portions145, 184 in a direction generally along arrow A (FIG. 3), connectionelements 120, 122 are compressed via the upwardly tapering guide surface141, 180. In this manner, when connection elements 120, 122 reach therespective exit portions 145, 184, connection elements 120, 122 areelastically deformed such that connection elements 120, 122 snap intorespective locking recesses or securement elements 140, 172 as shown inFIGS. 5A-5C. In this manner, as connection elements 120, 122 areelastically deformed such that connection elements 120, 122 snap intorespective locking recesses or securement elements 140, 172, connectionelements 120, 122 make an audible snapping or clicking sound thatenables a user to be informed that a secure connection has been made. Inother words, once connection elements 120, 122 slide over and pastrespective exit portions 145, 184 of tapered guide surfaces 141, 180,elastic connection elements 120, 122 snap back or return to theirundeformed position and lock within respective securement elements 140,172, i.e., with connection elements 120, 122 mechanically locked withinrespective securement elements 140, 172, injector adapter 12 isconnected to IV line adapter 18, such that, significant relativemovement between injector adapter 12 and IV line adapter 18 isprevented.

The locked position of FIG. 4 illustrates the elastically deformableconnection elements 120, 122 of injector adapter 12 in a locked positionin which connection elements 120, 122 are in their undeformed positionand are locked within respective securement elements 140, 172. Theunlocked position of FIG. 4 illustrates the elastically deformableconnection elements 120, 122 of injector adapter 12 in a deformedposition in which connection elements 120, 122 are deformed as theytravel through the respective upwardly tapering guide surfaces 141, 180of IV line adapter 18.

Referring to FIG. 3, once it is desired to disconnect injector adapter12 from IV line adapter 18, connection elements 120, 122 of injectoradapter 12 can be rotated in a counter-clockwise direction generallyalong arrow B to rotate connection elements 120, 122 out of engagementwith respective securement elements 140, 172. Step members 135, 173provide a component that allows connection elements 120, 122 of injectoradapter 12 to be rotated out from engagement with respective securementelements 140, 172. For example, as a rotational force is exerted onconnection elements 120, 122 to move connection elements 120, 122 in adirection generally along arrow B to move connection elements 120, 122out of securement elements 140, 172, connection elements 120, 122cooperate with a respective tapered exit recess step 147, 191 of IV lineadapter 18. The respective tapered exit recess steps 147, 191 of IV lineadapter 18 provide a ramp surface to deform respective connectionelements 120, 122 outwardly until connection elements 120, 122 advancebeyond, i.e., slide over and past, respective top step surfaces 149, 193of step members 135, 173 as shown in FIGS. 6A-6C. Once connectionelements 120, 122 slide over and past respective top step surfaces 149,193 of step members 135, 173, connection elements 120, 122 snap intorespective entry portions 153, 188 of disconnection paths 138, 171. Inthis manner, as connection elements 120, 122 are elastically deformedsuch that connection elements 120, 122 snap into respective entryportions 153, 188 of disconnection paths 138, 171, connection elements120, 122 make an audible snapping or clicking sound that enables a userto be informed that a disconnection has been made. As connectionelements 120, 122 snap into respective entry portions 153, 188 ofdisconnection paths 138, 171, connection elements 120, 122 return totheir undeformed or original position within respective entry portions153, 188 of disconnection paths 138, 171. Also, step members 135, 173can be used to tune resistance and provide tactile feel during adisconnection movement.

With connection elements 120, 122 in respective disconnection paths 138,171 of IV line adapter 18, a pulling force may be exerted in a directiongenerally along arrow C (FIG. 3) to pull injector adapter 12 out from IVline adapter 18. As connection elements 120, 122 of injector adapter 12are guided through respective disconnection paths 138, 171 of IV lineadapter 18 from respective entry portions 153, 188 to respective exitportions 154, 189 in a direction generally along arrow C (FIG. 3),connection elements 120, 122 are compressed via the upwardly taperingguide surfaces 150, 185. To prevent injector adapter 12 from beingeasily removed from IV line adapter 18, barrier exit walls 155, 190provide a physical barrier to prevent respective connection elements120, 122 from being easily removed from disconnection paths 138, 171.Once a force is exerted to deform connection elements 120, 122 so theyslide over and past respective barrier exit walls 155, 190, connectionelements 120, 122 return to their undeformed or original position pastbarrier exit walls 155, 190 and injector adapter 12 is removed from IVline adapter 18 as shown in FIG. 1.

The connection system of the present disclosure provides for quick andintuitive coupling and decoupling of two opposing medical devicecomponents through the use of a connection path and a disconnectionpath, the connection path being distinct from the disconnection path.Furthermore, the connection system of the present disclosure providesaudible and tactile connection feedback through the use of elasticallydeformable connection elements.

FIGS. 11A-11C illustrate the use of a connection system of the presentdisclosure to connect injector adapter 12 to vial adapter 14. Aspreviously discussed, the connection system of first and secondconnection elements 336, 339 of vial adapter 14, illustrated in FIGS.19A-19G, include similar components to the connection system of firstconnection element 133 and second connection element 134 of IV lineadapter 18 illustrated in FIGS. 12-14B, and the similar components aredenoted by a reference number followed by the letter A. For the sake ofbrevity, the similar steps of the use of a connection system of thepresent disclosure to connect injector adapter 12 to vial adapter 14will not be described in detail as the steps are the same as describedabove to connect injector adapter 12 to IV line adapter 18.

FIG. 27 illustrates a further exemplary embodiment of an IV line adapter18B and an injector adapter 12B. In one embodiment, injector adapter 12Bincludes slits 68B on opposing sides of connection elements 120B, 122B.

FIGS. 28-35 illustrate another exemplary embodiment. The embodimentillustrated in FIGS. 28-35 includes similar components to the embodimentillustrated in FIGS. 1-26, and the similar components are denoted by areference number followed by the letter A. For the sake of brevity,these similar components and the similar steps of using connectionsystem 132A (FIGS. 28-35) will not all be discussed in conjunction withthe embodiment illustrated in FIGS. 28-35.

Referring to FIGS. 28-35, in one embodiment, connection system 132Aincludes a connector 400, a membrane 402, and a first luer component 404which are compatible with a second luer component 406 and an IV line 408as will be discussed in more detail below.

Referring to FIGS. 28-31, connector 400 includes first end 410, opposingsecond end 412, and annular protrusion 414. In one embodiment, connector400 comprises an IV line adapter connector component. Connector 400provides a compact and accessible connector for connecting a cartridgeor barrel containing a reconstituted drug to an intravenous line or aninjection apparatus for administering a drug to a patient. First end 410of connector 400 includes a first connection element 133A of connectionsystem 132A. First connection element 133A of connector 400 forms aportion of a connection system of the present disclosure which iscompatible with a connection system 120, 122 of injector adapter 12which forms another portion of a connection system of the presentdisclosure as discussed above.

Referring to FIG. 30, first connection element 133A of connector 400includes a first connection path 136A, a first disconnection path 138A,and a first securement element 140A disposed between the firstconnection path 136A and first disconnection path 138A. In oneembodiment, first connection path 136A, first disconnection path 138A,and first securement element 140A together generally define a U-shapedpath. First connection path 136A is distinct from first disconnectionpath 138A. In this manner, the distinct connection and disconnectionpaths allow for the fine tuning of tactile and audible responsesseparately for connection and disconnection movements as described indetail above. In one embodiment, divider wall 139A is disposed betweenfirst connection path 136A and first disconnection path 138A. Referringto FIG. 30, connection system 132A of connector 400 includes firstdisconnection path 138A that is located on an opposite side of firstconnection path 136A relative to the embodiment illustrated in FIG. 2.In this manner, connection system 132A of connector 400 requires aninjector, such as injector adapter 12, to be rotated in a clockwisedirection to disconnect the injector from connector 400. In this manner,during the disconnecting step, an overall connector tightening to an IVline results during the use of connection system 132A as will bedescribed in more detail below.

Referring to FIGS. 29, 32, and 33, in one embodiment, system 132Aincludes a pierceable barrier membrane 402. Membrane 402 includes afirst end 430, opposing second end 432, and an annular groove 434.Referring to FIG. 29, membrane 402 is attachable to first end 410 ofconnector 400 by a press fit or interference fit. In one embodiment,membrane 402 is attached to connector 400 by pressing membrane 402within first end 410 of connector 400 such that annular protrusion 414of connector engages annular groove 434 of membrane 402 to securemembrane 402 to connector 400 as shown in FIG. 29. The assembly of themembrane 402 within a corresponding connector is described in moredetail below. The first end 430 of the membrane 402 defines a convexsurface, although other suitable shaped surfaces may be utilized. Thesecond end 432 of the membrane 402 defines a cavity 403 that extendstoward the first end 430 of the membrane 402. The cavity 403 terminatesbetween the first end 430 and second end 432 of the membrane at abouthalf a length of the membrane 402. The terminal end of the cavity 403may define a concave surface, although other suitable shaped surfacesmay be utilized. The cavity 403 tapers and narrows as it extends towardthe first end 430 of the membrane 402. The second end 432 of themembrane 402 includes an annular projection 405 extending away from thesecond end 432 of the membrane 402.

The pierceable barrier membrane 402 provides for a liquid and gas tightseal between a piercing member of a barrel assembly and the pierceablebarrier membrane 402 during fluid transfer of a medication to a patientso to minimize leakage and thereby prevent exposure of hazardousmedicaments to a user. Barrier membrane 402 provides a self-sealing sealthat, with a barrel assembly attached to connector 400, provides aleak-proof seal preventing any substance being administered to a patientfrom being exposed to a health care provider administering themedication. In one embodiment, barrier membrane 402 comprises aresilient material. For example, barrier membrane 402 is preferably aunitary device molded of any flexible, elastomeric materialconventionally used for fabricating gas-proof closures. Barrier membrane402 may be formed of a natural rubber material, polyurethane elastomers,butyl rubbers, or similar materials.

Referring to FIGS. 29 and 34, in one embodiment, system 132A includes amale or first luer component 404. First luer component 404 includesfirst end 440, opposing second end 442, threaded portion 444, andmembrane receiving portion 446. Referring to FIG. 35, a female or secondluer component 406 is attached to an end of IV line 408. The threadedportion 444 of first luer component 404 is engageable with a threadedportion 460 (FIG. 35) of second luer component 406 to secure first luercomponent 404 to second luer component 406 and IV line 408 as shown inFIG. 35. First luer component 404 is rotated in a clockwise directiongenerally along arrow CW (FIG. 35) relative to second luer component 406to tighten and secure threaded portion 444 of first luer component 404to threaded portion 460 of second luer component 406.

Referring to FIG. 29, first luer component 404 is attachable to secondend 412 of connector 400 by a press fit or interference fit. In oneembodiment, first luer component 404 is attached to connector 400 bypressing first luer component 404 within second end 412 of connector 400such that second end 432 of membrane 402 engages membrane receivingportion 446 of first luer component 404 to secure first luer component404, membrane 402, and connector 400 theretogether as shown in FIG. 29.

Referring to FIGS. 28-35, the use of connection system 132A of thepresent disclosure to connect a first medical device component, e.g.,injector adapter 12, to a second medical device component, e.g.,connector 400, will now be described. For the sake of brevity, thesimilar steps of using connection system 132A (FIGS. 28-35) will not allbe discussed in conjunction with the embodiment illustrated in FIGS.28-35. Connection system 132A includes similar steps as discussed indetail above with regards to connection system 132.

Referring to FIG. 35, once it is desired to disconnect an injector fromconnector 400, the injector can be rotated in a clockwise directiongenerally along arrow CW to rotate the injector out of engagement withfirst securement element 140A of connector 400 and to disconnect theinjector from connector 400. In this manner, during the disconnectingstep, an overall connector 400 tightening to an IV line 408 resultsduring the use of connection system 132A. For example, during thedisconnecting step, rotation in a clockwise direction to disconnect theinjector from connector 400 also causes the threaded portion 444 offirst luer component 404 to tighten to threaded portion 460 of secondluer component 406 thereby tightening connector 400 to IV line 408.

Referring to FIGS. 36A-36C, in one embodiment, the membrane 402 isassembled with a corresponding connector 502 by initial positioning theopposing end 432 of the membrane 402 within a central opening 504 of theconnector 502 as shown in FIG. 36A. Referring to FIG. 36B, the membrane402 is then pushed or forced into the opening 504 and past the annularprotrusion 506 of the connector 502. The annular protrusion 506compresses and engages the membrane 402 as the membrane 402 is insertedinto the connector 502. Referring to FIG. 36C, the membrane 402 ispushed into the connector 502 until the annular groove 434 of themembrane 402 is aligned with and receives the annular protrusion 506 ofthe connector 502 thereby creating an interference fit between theconnector 502 and the membrane 402. In particular, the intermediateportion of the membrane 402 between the first end 430 and the opposingend 432 of the membrane has an interference fit with the connector 502,which creates a positive internal pressure to promote self-sealing whenpierced with a cannula or engaged with another connector. Further, whenthe membrane 402 is assembled with the connector 502, the first end 430of the membrane extends beyond the connector 502 so that when themembrane 402 and connector 502 are mated with a corresponding membraneand connector, the first end 430 of the membrane is not restrictedthereby improving the resealing performance of the membrane 402 whenpierced by a cannula.

Referring to FIG. 37, in one embodiment, an assembly tool 510 isprovided to assist in the second step of inserting the membrane 402within the connector 502. The assembly tool 510 includes a centralopening 512 and a tapered surface 514, such as a frusto-conical shapedsurface. The central opening 512 of the assembly tool 510 is alignedwith the opening 504 of the connector 502. After positioning themembrane 402 adjacent to the assembly tool 510, the membrane is thenpushed and inserted into the opening 512 of the assembly tool 510 withthe membrane 402 engaging the tapered surface 514 of the tool 510 tocompress the membrane and allow for easier insertion of the membrane 402into the connector 502. The membrane 402 is otherwise assembled with theconnector 502 in the same manner as described above in connection withFIGS. 36A-36C with the annular groove 434 of the membrane receiving theannular protrusion 506 of the connector 502.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A membrane for a medical connector comprising: abody having a first end and a second end with a sidewall extendingbetween the first end and the second end, the sidewall of the bodydefining an annular recess, the second end of the body defining a cavitythat extends toward the first end of the body, the cavity comprising afirst cavity end and a second cavity end, the second cavity endpositioned about half a length of the body from the first cavity end,and the annular recess configured to receive a protrusion of the medicalconnector, wherein an annular projection extends from the second end ofthe body, wherein the annular projection has a diameter that is lessthan or equal to a diameter of the annular recess, wherein the first endof the body is configured to extend beyond the medical connector, andwherein a diameter of the first end of the body is greater than anopening diameter of a first end of the medical connector.
 2. Themembrane of claim 1, wherein the first end of the body includes a convexsurface.
 3. The membrane of claim 1, wherein the second cavity enddefines a concave surface.
 4. The membrane of claim 3, wherein thecavity is wider at the first cavity end than at the second cavity end.5. The membrane of claim 1, wherein the cavity is wider at the firstcavity end than at the second cavity end.
 6. The membrane of claim 1,wherein an inside corner defining the annular recess is radiused.
 7. Amedical connector comprising: a connector body defining an interiorspace, the connector body including a protrusion extending into theinterior space; and a membrane body having a first end and a second endwith a sidewall extending between the first end and the second end ofthe membrane body, the second end of the membrane body defining a cavitythat extends toward the first end of the body, and the sidewall of themembrane body defining an annular recess, wherein the protrusion of theconnector body is engaged with the annular recess of the membrane body,the membrane body is secured to the connector body via an interferencefit, and wherein a portion of the membrane body is received within theinterior space of the connector body, wherein an annular projectionextends from the second end of the membrane body, wherein the annularprojection has a diameter that is less than or equal to a diameter ofthe annular recess, wherein the first end of the membrane body extendsbeyond the connector body, and wherein a diameter of the first end ofthe membrane body is greater than an opening diameter of a first end ofthe connector body.
 8. The medical connector of claim 7, wherein thesidewall and the annular recess of the membrane body establish theinterference fit with the connector body.
 9. The the medical connectorof claim 7, wherein the first end of the membrane body includes a convexsurface.
 10. A method of assembling a medical connector comprising:providing a connector body defining an interior space, the connectorbody including a protrusion extending into the interior space;positioning a membrane adjacent to the connector body, the membranecomprising a membrane body having a first end and a second end with asidewall extending between the first end and the second end of themembrane body, the second end of the membrane body defining a cavitythat extends toward the first end of the body, and the sidewall definingan annular recess; and inserting a portion of the membrane body withinthe interior space of the connector body, elastically deforming themembrane body, and positioning the protrusion of the connector bodywithin the annular recess of the membrane body to secure the membrane tothe connector body via an interference fit, wherein an annularprojection extends from the second end of the membrane body, wherein theannular projection has a diameter that is less than or equal to adiameter of the annular recess, wherein the first end of the membranebody extends beyond the connector body, and wherein a diameter of thefirst end of the membrane body is greater than an opening diameter of afirst end of the connector body.
 11. The method of claim 10, furthercomprising: positioning an assembly tool on a first end of the connectorbody adjacent to the interior space, the assembly tool having a conicalsurface; and elastically deforming the membrane body prior to insertingthe portion of the membrane body within the interior space of theconnector body by engaging the conical surface of the assembly tool withthe portion of the membrane body.